The invention relates to measuring whether blood coagulation times are in a normal range or not, and more particularly for measuring PT (prothrombin time) and aPTT (activated partial thromboplastin time) coagulation values to produce qualitative or quantitative results. The invention is a lightweight, portable, disposable device which can give immediate results at a hospital patient's bedside, or can be used for patient self-monitoring in a home setting.
Current trends in the diagnostics industry are full laboratory automation, and point-of-care testing. Full laboratory automation for thrombosis/hemostasis is exemplified by the MDA-180 (Organon Teknika, Durham, N.C.) where, e.g., samples from patients all over a hospital are delivered to a central location where the automated apparatus is located. Patients' blood samples are placed into the machine, after which a variety of assays are performed and results reported. The results are then sent/transmitted back to the area where the patient is located for interpretation by the doctor.
Point-of care testing, on the other hand, though complementary to full laboratory automation, involves smaller devices, often handheld devices with disposable components, which can give results at the patient's bedside (or at home, if the device is for home use). In point-of-care testing, rather than sending a blood sample to a central location for testing, a sample of blood can be placed in a small device at the patient's bedside (or at a location near the patient) so that a test result can be available more quickly. This savings in time can be crucial when the point-of-care testing is for a thrombotic or hemophiliac condition.
In the long run, the trend is for testing devices to become more simple, more portable and more flexible in use. In the coagulation field, rapid technology-driven change is transforming the market for products used in monitoring the coagulation status in heart patients and others treated with anti-coagulant therapy. Also, with managed healthcare resulting in shorter hospital stays, the desirability increases for testing that does not require the use of the central laboratory, and for devices that can be used at home, thus allowing patients to be discharged from the hospital more quickly.
Furthermore, with regard to point-of-care testing in a home setting, studies have shown that self testing can improve patient treatment when compared to the lack of self monitoring of coagulation therapy. Numerous studies have indicated that more frequent PT testing increases the effectiveness and safety of anticoagulant therapy. Effectiveness is measured by a low incidence of thromboemboli, that is, blood clots which can result when the therapeutic dosage is too low. Safety is measured by few or no bleeding incidents, which can occur when the therapeutic dose is too large. With self testing at home, the therapeutic dosage can more easily be kept within a safe range thus improving the treatment of the individual undergoing anticoagulant therapy.